Senior Technology Transfer MS&T Engineer

Job description

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August! August Bioservices is seeking a Technology Transfer MS&T Engineer (Technical Services) reporting to the Sr. Director of Technical Operations. The candidate will serve as a Technical Services expert for aseptic process implementations and is a core team member for customer facing collaborations. An extensive understanding of pharmaceutical sterile processing principles, process development and scale-up approaches is required. Knowledge and expertise in Biologics are preferred with experience in single-use system (SUS) technologies and compliant process segregation as an important core service August Bioservices provides to clients. Technical understanding and application of current equipment, process controls, identification of support utilities and sampling technologies is an important competency as they relate to development, optimization, and technology transfer of small and large molecule fill/finish operations. The incumbent is responsible for tasks associated with the technology transfer for sterile drug products and Biologics. The responsibilities include working with Formulation Development, Process Engineers, Analytical Development, Production, Quality, and Regulatory to identify product and process criticalities and finding scientific data driven solutions to any Technology Transfer process. In Addition, the individual in this role is responsible for working on multiple client-based projects in a fast-paced environment. Apart from Technology Transfer activities, the position requires writing of technical documents to support, including protocols, reports, SOPs, Work Instruction, Batch records, and technical and risk assessments. The Engineer in this role is expected to work with other Technology technical services/process engineers to support process development within a team-based environment. This position will be responsible for participating in interdisciplinary teams and primary contact for the operations team throughout the product’s lifecycle. The Engineer is supported directly by facility engineers as required. ### Responsibilities - Review of technology transfer documents such as product development reports, batch manufacturing and/or packaging records to provide the technical analysis for the overall process. - Based on analysis, identify gaps in capabilities needed to support new product/process introductions and recommend solutions to close these gaps. - Lead evaluations of collected data during development and scale-up activities and recommend opportunities for process optimization - Lead training and familiarization efforts for new processes and equipment including development of operation SOP and work instructions - Lead and/or support execution of Toxicological, Clinical, Scale up, Exhibit/Registration, Commercial and process Performance Qualification with production team inside production areas. - Lead the evaluation and selection of new equipment in support of fill/finish production operations in collaboration with client and internal stakeholders. - Work with R&D, Facilities and Validation team on process implementation to develop a detailed plan based on the approved scope of work - Participate in multidisciplinary project teams through the complete product transfer to support ongoing client projects on-time - Conduct phase specific studies based on DOE (Design of Experiments) as needed, for formulation optimization and process confirmation. - Incorporate Quality-By-Design (QbD) approach in the product development program to improve the drug formulation and manufacturing process. - Investigations and Corrective Actions analysis and support. - Write comprehensive technical reports, business evaluations, process description with or without supervision. - Write documents including master batch records, protocols and reports, SOPs, Work Instructions, and other necessary technical documents. - Troubleshoot and resolve simple to moderately complex issues, diagnosing technical problems and identifying short and long-term solutions - Working with Cross-Functional Team leads to identifying opportunities for enhancements and champion projects which will improve overall site function. - Proficient in Quality system software such as Master control and related task such MOC (change control), CAPA, Issue Reviews, Work Orders, collaboration, and approval of various documents. ### Education - The candidate requires B.S in Pharmaceutical Sciences (or equivalent), M.S in Pharmaceutical Sciences (or equivalent), or PhD in Pharmaceutical Sciences (or equivalent). - 5+ years of equivalent experience - Experience in Pharmaceutical aseptic process implementation including new equipment, sterile filtration, Sterilize-in-Place principles, product dosing technologies and GMP fundamentals in production environments - Experience in developing technical recommendations in support of new process introductions ### Additional Skills - Knowledge of High-Pressure Homogenization, Rotary Evaporators, High Shear Homogenizers, Microfluidizers, Extrusion, Lyophilization, PFS, Vial filling operations, etc. - Knowledge of pharmaceutical processing technologies such as mixers, transfer pumps, temperature control devices - Knowledge of appropriate process requirements for sterile operations including: compounding, sterile filtration, aseptic formulation, sterile filling for vials, pre-filled syringes and flexible IV bags - Software - Minitab® (or equivalent), Microsoft Office® etc. ### Phyiscal Requirements **ADA Accommodation Notice** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. **Physical Requirements** - Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks. - Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment (PPE). - Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities. - Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures. - Regularly required to stand and walk for extended periods on hard warehouse and production flooring throughout the shift. - Frequently required to bend, stoop, kneel, and reach in both upward and downward directions. - Must be able to occasionally lift and/or move up to 50 lbs; frequently lift and/or move up to 40 lbs; and constantly reposition or transfer objects of negligible weight. - Must be able to push and pull loaded carts, pallet jacks, and hand trucks across production and warehouse surfaces. - Required to safely climb ladders to access materials stored at height. - Must be able to operate powered industrial equipment including forklifts and electric pallet jacks, including the physical demands associated with vibration exposure and repetitive upper-body movement. - Required to work in varying temperature environments, including ambient, refrigerated, and frozen storage areas, using appropriate PPE. - Must be able to wear and work in full cleanroom gowning (including gown, gloves, mask, hairnet, and shoe covers) for extended periods as required by the production area. - Specific vision requirements include close vision, distance vision, peripheral vision, depth perception, and the ability to read small print on labels and batch documents.